MAUDE Adverse Event Report: ABBOTT MEDICAL MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR); CATHETER, STEERABLE

Catalog Number SGC0701

Device Problem Unintended Movement (3026)

Patient Problem Pericardial Effusion (3271)

Event Date 12/07/2023

Event Type  Injury  

Manufacturer Narrative

The device will not be returned for evaluation as the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that a mitraclip procedure was performed to treat mitral regurgitation (mr) with a grade of 4.The transseptal puncture was performed and a steerable guide catheter (sgc) was placed across the septum.After removing the trannseptal wire and dilator from the sgc, the sgc was inadvertently withdrawn into the right atrium, losing the transseptal access.Imaging was challenging and it was not possible to find the transseptal puncture.Another trannseptal device was advanced and a second transseptal puncture was performed.The sgc was inserted across the septum into the left atrium.An enlarging pericardial effusion was observed.The procedure was discontinued, and the pericardial effusion was drained via pericardiocentesis.Once the effusion had been drained, the sgc was removed from the patient.The mr remained at a grade of 4.The pericardial effusion was observed for approximately 30 minutes.The pericardial effusion continued to become larger.The patient was transferred for open heart surgery.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported united movement associated with the device inadvertently withdrawn into the right atrium appears to be due to the user technique.The reported poor image resolution appears to be due to procedural conditions.The cause of the reported pericardial effusion cannot be determined.Additionally, the reported patient effect of pericardial effusion is listed in the instructions for use, and is a known possible complication associated with mitraclip procedures.The reported medical intervention, prolonged hospitalization, and surgical intervention were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: MITRACLIP¿ G4 STEERABLE GUIDE CATHETER (MDR)
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005070406; 3885 bohannon drive; menlo park CA 94025
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18416122
• MDR Text Key: 331577064
• Report Number: 2135147-2023-05749
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 08717648231025
• UDI-Public: 08717648231025
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Catalogue Number: SGC0701
• Device Lot Number: 30314R1025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization